Reporting to Regulatory Authorities Procedure - ISO 13485

Reporting to Regulatory Authorities Procedure - ISO 13485

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ISO 13485:2016 QMS Template - Reporting to Regulatory Authorities Vigilance Procedure (QMS.8.2.3 - QP)

Enhance your Quality Management System with our ISO 13485:2016 compliant Vigilance Procedure template, expertly crafted by the professionals at Patient Guard. Our Medical Device Quality Assurance and Regulatory Affairs document templates are developed by experienced experts, ensuring they meet the specific requirements of each clause and section of the relevant standards or regulations.

Why Choose Our Template?

  • Expertly Designed: Created by seasoned Quality Assurance and Regulatory Affairs specialists, our templates ensure full compliance with ISO 13485:2016 standards.
  • Easy Customization: Fully editable in Microsoft Word, our templates allow you complete control to modify and tailor them to your specific business needs and branding.
  • Compliance Assurance: Utilizing our template helps you maintain an effective Vigilance Procedure, demonstrating robust quality management as required by ISO 13485:2016.

What is Vigilance Reporting?

Vigilance Reporting is the process of assessing, investigating, and reporting user complaints and incidents where patient injury, adverse health effects, or death occur due to medical device misuse or malfunction. The purpose of this procedure is to:

  • Define the actions your organization will take following a notification of an incident reportable to or by the Competent Authorities.
  • Ensure these actions align with applicable reporting responsibilities.
  • Establish vigilance and post-market surveillance for all products for which your organization is the legal manufacturer.

How Does Vigilance Reporting Fit Into the QMS?

The Vigilance Procedure forms part of your evidence demonstrating your compliance with ISO 13485, specifically in managing and reporting incidents. This includes documents such as:

  • The Management Responsibilities Procedure
  • The Post-Market Surveillance Plan
  • The Complaint Handling Procedure

This template ensures that your Vigilance Reporting process is thorough, compliant, and effectively integrated into your QMS.

How Will Having a Vigilance Procedure Help My Organisation?

The Vigilance Procedure serves a pivotal role within your organization’s QMS and contributes to the business’s commitment to quality and safety. It:

  • Defines the process for handling reportable incidents, ensuring regulatory compliance.
  • Provides a structured approach to document and manage incidents effectively, enhancing product safety.
  • Ensures that post-market surveillance is ongoing, identifying potential issues early.

Why Patient Guard?

Stay ahead with Patient Guard’s consultancy services, offering a cost-effective solution for all your Quality Management System needs. For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at

Visit our blog for updates on regulatory and quality assurance news, and take the next step in enhancing your Quality Management System with Patient Guard.

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